Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.

Phase II Study of Adjuvant Simultaneously Integrated Boost Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.

This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(<1cm) hepatectomy in patients with HCC. Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions, mainly depending on the dose constraints of OARs. The primary endpoint is the 3-year OS, the secondary endpoints are disease-free survival, patterns of failure, toxic events and local control rate.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma; Radiotherapy; Narrow Margin
• Intervention / Treatment: Radiation: Adjuvant SIB radiotherapy

Detailed Description

Surgical resection is the primary treatment for HCC. However, it is associated with a high rate of recurrence and death. Based on the results of our retrospective study and phase II study, adjuvant radiotherapy is an effective, tolerable, and promising adjuvant regimen in patients with narrow-margin(<1cm) after hepatectomy. The 3-year and 5-year OS rates of 88.2% and 72.2% were significantly higher than the expected rates based on published reports and exceeded our predetermined threshold. However, there is no standard for the prescription dose. The high risk area of recurrence is mostly close to the blood vessels in the tumor bed, and simultaneously integrated boost (SIB) technique can optimize the target dose while protecting normal tissues. So, the investigators conducted this single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant SIB radiotherapy following narrow-margin(<1cm) hepatectomy in patients with HCC.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bo Chen, MD; Phone Number: 00861324000876; Email: chenboo@outlook.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Bo Chen
    • Principal Investigator: Bo Chen
    • Contact: Bo Chen; Phone Number: 00861324000876; Email: chenboo@outlook.com
    • Sub-Investigator: Yirui Zhai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pathological diagnosis of HCC after hepatectomy with narrow pathological margins (< 1 cm)
• Age > 18 years
• Recovery from surgery with an Eastern Cooperative Oncology Group performance status score of 0 or 1
• Child-Push Score: A5-A6
• Estimated life expectancy > 3 months
• No distant metastasis (M0)
• Blood routine examination: Hb≥80g/L, ANC≥1.0x10^9/L, PLT≥50x10^9/L
• Hepatic function: alanine transaminase(ALT) and aspartate transaminase(AST) ≤1.5 times ULN; or ALT ≤ULN and AST ≤6 times ULN exclude possibility of heart disease
• Renal function: creatinine(CRE) and blood urea nitrogen(BUN)≤1.5 times ULN
• Voluntary to participate and sign informed consent

Exclusion Criteria:

• History of malignancies, except for basal cell skin carcinoma and in situ carcinoma of the cervix
• Had prior abdominal irradiation
• Had prior liver transplantation
• Had serious myocardial disease or renal failure
• Had moderate or severe ascites with obvious symptoms
• Duration from surgery ≥ 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adjuvant SIB radiotherapy; Adjuvant integrated boost radiotherapy following narrow-margin hepatectomy in patients with HCC.	Radiation: Adjuvant SIB radiotherapy; Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions,mainly depending on the dose constraints of OARs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 3-year Overall Survival	The 3-year overall survival was calculated from the date of surgical resection to the date of death from any cause.	up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival (DFS)	Disease-free survival (DFS) was calculated from the date of surgical resection to the date of the first recurrence or death from HCC	up to 36 months
Pattern of Failure	The type of recurrence (locoregional failures or distant failure)	up to 36 months
Toxic Events	Toxic events was evaluated during received protocol therapy according to CTCAE 4.03	up to 36 months
Local Control Rate	Patients with stable disease [SD], partial response [PR] or complete response[CR] were recorded as local control.	up to 36 months

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): January 26, 2024
• Primary Completion (Estimated): December 12, 2025
• Study Completion (Estimated): December 12, 2026

Study Registration Dates

• First Submitted: December 25, 2023
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; Narrow Margin; Adjuvant Simultaneously Integrated Boost Radiotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: NCC4255

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No